Efficacy of early administration of thrombomodulin alfa in patients with sepsis-induced disseminated intravascular coagulation: subanalysis from post-marketing surveillance data

Introduction

We hypothesize that the early administration of thrombomodulin alfa (TM-alfa) (Recomodulin^® injection; Asahi Kasei Pharma Corporation, Tokyo, Japan) could improve mortality in patients with sepsis-induced disseminated intravascular coagulation (DIC). TM-alfa has been approved for use as a curative medicine for DIC in Japan from 2008 that was examined in a multicenter, randomized, clinical trial [1].

Methods

DIC was diagnosed based on the Japanese Association for Acute Medicine (JAAM) criteria. From May 2008 to April 2010, a total of 1,787 patients with sepsis-induced DIC from post-marketing surveillance data [2] were analyzed. The survival rates on day 28 after the last TM-alfa administration were evaluated.

Results

The 28-day survival rate was 64.5%. Use of other anticoagulants before and after TM-alfa administration did not affect the survival rate (present vs. absent: 63.8% vs. 65.2% (P = 0.782) and 62.5% vs. 65.3% (P = 0.606) respectively). The survival rate decreased significantly in proportion to the duration of DIC before TM-alfa administration (P < 0.001). More precisely, the 28-day survival rate was 66.4% when TM- alfa was injected on the same day that DIC was diagnosed, whereas it was 48.5% and 31.1% when TM-alfa was started 4 days later and 7 days or more after DIC was diagnosed, respectively. These differences were significant (P = 0.033 and P < 0.001, respectively).

Conclusion

The early administration of TM-alfa may be effective for patients with sepsis-induced DIC diagnosed based on the JAAM criteria.